A Study to Determine the Effect of 500 mg Oral Dose of KD025 in Healthy Male and Post-menopausal Female Subjects

NCT05918614 | Completed Phase 1

• 2 other identifiers: KD025-103U1111-1290-9655
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 500 mg oral BID dose of KD025 in healthy male and post-menopausal female participants.

Conditions

Immune System Disorder (Healthy Volunteer)

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events and serious adverse events

  Number of participants with adverse events and serious adverse events

  Up to approximately 58 days

Secondary Outcomes (7)

• Cmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

  Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

• Tmax of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

  Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

• Cmin of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

  Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

• AUC0 -τ of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

  Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

• AUCinf of KD025 and its metabolites [M1 (KD025m1) and M2 (KD025m2)]

  Predose and multiple timepoints up to 30 hours postdose on Days 1 and 28

Study Arms (2)

KD025

EXPERIMENTAL

500 mg KD025 administered orally twice daily (BID) for 28 days

Drug: Belumosudil mesylate

Placebo

PLACEBO COMPARATOR

Placebo administered orally BID for 28 days

Drug: Placebo

Interventions

Belumosudil mesylate DRUG

Pharmaceutical form: capsule; Route of administration: oral

Also known as: KD025, SAR445761

KD025

Placebo DRUG

Pharmaceutical form: capsule; Route of administration: oral

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants between the ages of 18 and 55 years, inclusive.
• Female who is not of reproductive potential.
• Able to provide written informed consent prior to the performance of any study specific procedures.
• Body mass index (BMI) range of 19-30 kilogram per square meter (kg/m2), inclusive.

You may not qualify if:

• Past or present disease that is judged by the investigator to have the potential to interfere with the study procedures, compromise safety, or affect the PK evaluations.
• Known sensitivity to Rho-associated coiled-coil containing serine/threonine protein kinases (ROCK2) inhibitor agents or to any of the constituents of the KD025 formulation.
• The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Sponsors & Collaborators

• Kadmon, a Sanofi Company: lead

Study Sites (1)

Investigational site

Buffalo, New York, 14202, United States

Location

MeSH Terms

Conditions

Immune System Diseases

Interventions

KD025

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: March 28, 2014
• Primary Completion: June 7, 2014
• Study Completion: June 7, 2014
• Last Updated: June 26, 2023

Record last verified: 2023-06-14

Data Sharing

• IPD Sharing: Will share

Locations

US (1)